LYRICA 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PREGABALIN

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

N03AX16

Pharmaceutical form:

CAPSULES

Composition:

PREGABALIN 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

Therapeutic group:

PREGABALIN

Therapeutic area:

PREGABALIN

Therapeutic indications:

Lyrica is indicated for the:- Treatment of peripheral and central neuropathic pain in adults. - Management of Fibromyalgia.- Treatment of Generalised Anxiety Disorder (GAD) in adults.

Authorization date:

2020-06-30

Patient Information leaflet

Lyrica PIL CC 110822
Pfleet 2022-007662, 2022-0077909
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
LYRICA
® 25 MG
LYRICA
® 50 MG
LYRICA
® 75 MG
LYRICA
® 100 MG
LYRICA
® 150 MG
LYRICA
® 200 MG
LYRICA
® 225 MG
LYRICA
® 300 MG
CAPSULES
ACTIVE INGREDIENT:
PREGABALIN 25, 50, 75, 100, 150, 200, 225, 300 MG
Inactive ingredients and allergens: see section 2 under "Important
information about some of
this medicine's ingredients" and section 6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others, it may harm them,
even if it seems to you that their medical condition is similar to
yours.
This medicine is not intended for treatment of children and
adolescents under 18 years of
age.
1. WHAT IS THE MEDICINE INTENDED FOR?
For treatment of neuropathic (neural) pain in adults, for treatment of
fibromyalgia and for
treatment of generalised anxiety disorder in adults.
THERAPEUTIC GROUP:
A gamma-aminobutyric acid analog.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient or to any of the
other ingredients
contained in this medicine (listed in section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
REFER TO YOUR DOCTOR BEFORE TAKING THE MEDICINE.
•
Some patients taking Lyrica have reported allergic effects. These
effects include swelling
of the face, lips, tongue and throat, as well as diffuse skin rash. If
you experience one or
more of these effects, refer to a doctor immediately.
Lyrica PIL CC 110822
Pfleet 2022-007662, 2022-0077909
•
Serious skin rashes including Stevens-Johnson syndrome and toxic
epidermal
necrolysis have been reported in association with Lyrica. Stop using
the medicine and
refer to a doctor imm

Summary of Product characteristics

Lyrica LPD CC 070722
Page 1 of 14
Pfleet 2022-0075766, 2021-0069599
1.
NAME OF THE MEDICINAL PRODUCT
LYRICA
®
25 mg
LYRICA
®
50 mg
LYRICA
®
75 mg
LYRICA
®
100 mg
LYRICA
®
150 mg
LYRICA
®
200 mg
LYRICA
®
225 mg
LYRICA
®
300 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225
mg or 300 mg of pregabalin.
_ _
Excipients with known effect:
[25mg] Each capsule contains 35 mg lactose monohydrate.
[50mg] Each capsule also contains 70 mg lactose monohydrate.
[75mg] Each capsule also contains 8.25 mg lactose monohydrate.
[100mg] Each capsule also contains 11 mg lactose monohydrate.
[150mg] Each capsule also contains 16.50 mg lactose monohydrate.
[200mg] Each capsule also contains 22 mg lactose monohydrate.
[225mg] Each capsule also contains 24.75 mg lactose monohydrate.
[300mg] Each capsule also contains 33 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
25 mg capsule: White hard gelatin capsule, marked “Pfizer” on the
cap and “PGN 25” on the body with black ink.
50 mg capsule: White hard gelatin capsule, marked “Pfizer” on the
cap and “PGN 50” on the body with black ink. The body
is also marked with a black band.
75 mg capsule: White and orange hard gelatin capsule, marked
“Pfizer” on the cap and “PGN 75” on the body with black ink.
100 mg capsule: Orange hard gelatin capsule marked “Pfizer” on the
cap and “PGN 100” on the body with black ink.
150 mg capsule: White hard gelatin capsule, marked “Pfizer” on the
cap and “PGN 150” on the body with black ink.
200 mg capsule: Light orange hard gelatin capsule, marked “Pfizer”
on the cap and “PGN 200” on the body with black ink.
225 mg capsule: White and light orange hard gelatin capsule, marked
“Pfizer” on the cap and “PGN 225” on the body with
black ink.
300 mg capsule: White and orange hard gelatin capsule, marked
“Pfizer” on the cap and “PGN 300” on the body with black
ink.
4.
CLINIC